Medicine guide

Sinus Severe

325 mg + 200 mg + 5 mg · Tablet, Film Coated

  • Available without prescription
  • Expectorant
Made by
Strategic Sourcing Services LLC

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-12-12

What it is

Pain reliever/fever reducer Expectorant Nasal decongestant

Used for
  • Headache nasal congestion minor aches and pains sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever
How to take it

Adults and children 12 years and over: take 2 caplets every 4 hours swallow whole - do not crush, chew, or dissolve

do not take more than 10 caplets in 24 hours

Full directions ↓
Do not take it if

With any other drug containing acetaminophen (prescription or nonprescription).

All warnings ↓
Good to know
  • Sold without a prescription
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
28other products contain Acetaminophen, Guaifenesin, Phenylephrine Hcl — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:

  • headache nasal congestion minor aches and pains sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever

From the official label · 2025-12-12 · DailyMed

Do not take it if

  • with any other drug containing acetaminophen (prescription or nonprescription).
  • If you are not sure whether a drug contains acetaminophen,
  • ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug.
  • If you do not know if your prescription drug contains an MAOI,
  • ask a doctor or pharmacist before taking this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Quoted from the official label, section “OTC — Do Not Use”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • do not take more than directed
  • adults and children 12 years and over
  • take 2 caplets every 4 hours swallow whole - do not crush, chew, or dissolve
  • do not take more than 10 caplets in 24 hours
  • children under 12 years:
  • ask a doctor

Quoted from the official label, section “Dosage & Administration”.

Ask a doctor first if

cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema heart disease thyroid disease diabetes liver disease high blood pressure difficulty in urination due to enlargement of the prostate gland

Quoted from the official label, section “OTC — Ask Doctor”.

Ask a pharmacist first if

you are taking the blood thinning drug warfarin.

Quoted from the official label, section “OTC — Ask Doctor/Pharmacist”.

Stop and get help if

  • nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts.
  • These could be signs of a serious condition.

Quoted from the official label, section “OTC — Stop Use”.

Other warnings

  • Liver warning: This product contains acetaminophen.
  • Severe liver damage may occur
  • if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert:
  • Acetaminophen may cause severe skin reactions.
  • Symptoms may include:
  • blisters rash skin reddening If a skin reaction occurs,
  • stop use and seek medical help right away.
  • Do not use with any other drug containing acetaminophen (prescription or nonprescription).
  • Ask a doctor before use
  • if you have cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema heart disease thyroid disease diabetes liver disease high blood pressure difficulty in urination due to enlargement of the prostate gland
  • Ask a doctor or pharmacist before use
  • if you are taking the blood thinning drug warfarin.
  • When using this product do not exceed recommended dosage.
  • Stop use and
  • ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts.
  • Keep out of reach of children.
  • do not exceed recommended dosage.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Keep away from children

  • In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for
  • adults as well as for children even
  • if you do not notice any signs or symptoms.

Quoted from the official label, section “OTC — Keep Out of Reach of Children”.

How to store it

  • each caplet contains:
  • sodium 3 mg TAMPER EVIDENT:
  • DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

Quoted from the official label, section “Storage and Handling”.

What kind of medicine it is

Pain reliever/fever reducer Expectorant Nasal decongestant

Quoted from the official label, section “OTC — Purpose”.

Other ingredients

Relevant if you react to a dye, a preservative, lactose or gluten.

corn starch, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Quoted from the official label, section “Inactive Ingredients”.

Questions about this product

Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Quoted from the official label, section “OTC — Questions”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

  • Titanium dioxidetitanium dioxideA whitening agent no longer allowed in food in the EU (E171).

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (31)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Hide versions whose label lists:

Showing 31 of 31

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

Details

Made byStrategic Sourcing Services LLC
Active substanceAcetaminophen, Guaifenesin, Phenylephrine Hcl
Used inBreathing, airways, allergies and cough
Strength325 mg + 200 mg + 5 mg
FormTablet, Film Coated
RouteOral
Packs2 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK
NDC70677-1259

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Other strengths and forms

12 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.